Senior Analyst, Quality Standards & Governance

6090-Johnson & Johnson Services Inc. Legal Entity; New Brunswick (NJ); On-site; USD 94,000 - 152,000; Full time

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Retirement plan

Job summary

Johnson & Johnson is seeking a Senior Analyst, Standards Specialist, to join the Enterprise Regulatory Intelligence team within Enterprise Regulatory Compliance. You will manage revisions to enterprise quality standards, coordinate with SME stakeholders, and ensure timely publication of updates across internal systems and the standards website.

The role emphasizes governance, data integrity, and driving continuous improvements in the standards program, with a focus on leveraging AI tools under

Qualifications

• Bachelor’s degree in life sciences, quality, regulatory affairs, engineering, or related field.
• Minimum of five years of quality experience in a regulated industry (pharmaceuticals or medical devices preferred).
• Experience with controlled-document authoring, revision, and approval workflows in a regulated setting.
• Strong knowledge of GxP/medical device documentation concepts and quality systems.

Responsibilities

• Coordinate end-to-end revisions of enterprise quality standards and track change requests.
• Collaborate with SMEs and standards owners to update content.
• Route documents through the DMS for review and approval per procedures.
• Maintain the calendar for periodic reviews and ensure on-time completion of updates.
• Monitor and report program metrics (cycle time, backlog, revisions) and identify improvement opportunities.
• Support updates to standards tools and maintain traceability of references and sections.

Skills

Facilitation

Attention to detail

Program metrics

Cross-functional coordination

Written communication

Process improvements

AI literacy

Regulatory affairs

Education

Bachelor's degree in life sciences or related field

Tools

Veeva

SharePoint

Job description

Johnson & Johnson is seeking a Senior Analyst, Standards Specialist, to join the Enterprise Regulatory Intelligence team within Enterprise Regulatory Compliance. You will manage revisions to enterprise quality standards, coordinate with SME stakeholders, and ensure timely publication of updates across internal systems and the standards website.

The role emphasizes governance, data integrity, and driving continuous improvements in the standards program, with a focus on leveraging AI tools under